MAUDE Adverse Event Report: POSEY PRODUCTS LLC POSEY BED 8060; PATIENT BED WITH CANOPY/RESTRAINTS

Model Number 8060

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Fall (1848)

Event Date 01/14/2018

Event Type  malfunction  

Manufacturer Narrative

Product is scheduled to be returned but has not been received in for evaluation at the time of this report.Therefore, this report is based solely on the information provided by the customer.At this time there is not evidence that a manufacturing non-conformity contributed to the reported complaint and the instructions for use were reviewed and determined to provide adequate instructions and warning for the safe and effective use of the device.Therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.(b)(4).No product returned at this time.

Event Description

Customer reported the patient was found on the floor and the zipper was found open.The nurse believes the patient fell due to the equipment not being zipped up.No patient injuries and no medical attention required.

Event Description

Supplemental required for additional information.

Manufacturer Narrative

The product was not returned for analysis.Without the device, the reported issue could not be confirmed and possible causes of the failure could not be determined.Historical data review showed two other complaints against similar product where the zipper would not close.However, both times there were noticeable damages to the zipper and there was no serious injury associated with the complaints.The instructions for use (ifu) were reviewed and determined to provide clear and concise warning against putting a damaged canopy into use with a patient.The ifu states: "warning, never use the posey bed if there is damage to the canopy, access panels or zippers.A failure to heed this warning may result in patient escape or unassisted bed exit, which may lead to serious injury or death from a fall" and also "test that all zippers open easily and close securely along the entire length of the zipper.Inspect zipper coils for any kinks or misalignment.If any are identified, zip and unzip the zipper.If condition continues, do not use product." at this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint.It was noted the product had been manufactured over 3 years ago, and it's possible normal wear and tear of the product contributed to customer's complaint.Therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.(b)(4).

• Brand Name: POSEY BED 8060
• Type of Device: PATIENT BED WITH CANOPY/RESTRAINTS
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck rd; arcadia CA 91006
• MDR Report Key: 7220111
• MDR Text Key: 98436701
• Report Number: 2020362-2018-00005
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• PMA/PMN Number: K113355
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 8060
• Device Catalogue Number: 8060
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2018
• Initial Date FDA Received: 01/25/2018
• Supplement Dates Manufacturer Received: 03/08/2018
• Supplement Dates FDA Received: 03/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1